Device for collecting a biological sample

ABSTRACT

A device for collecting a biological sample in a patient includes a collection portion having a first axial end portion and a second axial end portion. The second axial end portion has a collapsed position and an expanded position. The second axial end portion moves in an axial direction relative to the first axial end portion when the second axial end portion moves between the collapsed position and the expanded position. The second axial end portion extends axially into the first axial end portion and has a concave shape when in the collapsed position. The second axial end portion is convex when in the expanded position.

RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 16/405,634, filed May 7, 2019, which is a divisional of U.S.application Ser. No. 15/103,638, filed Jun. 10, 2016, now U.S. Pat. No.10,660,621, which is a U.S. 371 National Stage of PCT/US2014/070060,filed Dec. 12, 2014, which claims priority to and the benefit ofProvisional Application No. 61/915,029, filed Dec. 12, 2013, the subjectmatter of each of which are incorporated herein by reference in theirentireties.

GOVERNMENT SUPPORT

This invention was made with government support under Grant Nos.P50CA150964, UO1CA152756, U54CA163060 awarded by The National Institutesof Health. The United States government has certain rights to theinvention.

BACKGROUND OF THE INVENTION

The present invention is directed to a device for collecting abiological sample, and more specifically, to a device for collecting abiological sample, such as tissue, cells, protein, RNA and/or DNA froman esophagus of a patient.

A known issue collection device includes an expandable device withlongitudinally extending folds. The expandable device expands radiallyat a collection site within a body lumen, such as an esophagus. Afterthe device is expanded, tissue is collected from the collection site.The expandable device is deflated after tissue is collected. The foldstrap collected tissue when the device is deflated after collection oftissue. The known tissue collection device may be inserted through anendoscope to the collection site or via standard catheter intubationtechniques.

SUMMARY OF THE INVENTION

The present invention relates to a device for collection a biological asample in a patient. The device includes a collection portion having afirst axial end portion and a second axial end portion. The second axialend portion has a collapsed position and an expanded position. Thesecond axial end portion moves in an axial direction relative to thefirst axial end portion when the second axial end portion moves betweenthe collapsed position and the expanded position.

In another aspect of the present invention, a device for collecting abiological sample in a patient includes a collection portion having afirst axial end portion and a second axial end portion. The second axialend portion has a collapsed position and an expanded position. Thesecond axial end portion extends axially into the first axial endportion and has a concave shape when in the collapsed position. Thesecond axial end portion is convex when in the expanded position.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present invention will becomeapparent to those skilled in the art to which the present inventionrelates upon reading the following description with reference to theaccompanying drawings, in which:

FIG. 1 is a schematic pictorial view of a biological sample collectiondevice constructed in accordance with the present invention;

FIG. 2 is a schematic pictorial view of the collection device of FIG. 1shown in a collapsed position;

FIG. 3 is a sectional view of the collection device of FIG. 2;

FIG. 4 is an enlarged plan view of a projection or bristle of thecollection device

FIG. 5 is a sectional view of the projection taken along the line 5-5 inFIG. 4;

FIG. 6 is a schematic pictorial view of a collection device constructedin accordance with a second embodiment of the present invention;

FIG. 7 is a schematic pictorial view of a collection device constructedin accordance with a third embodiment of the present invention;

FIG. 8 is a schematic pictorial view of a collection device constructedin accordance with a fourth embodiment of the present invention;

FIG. 9 is a side view of a projection of the collection device of FIG.8;

FIG. 10 is a schematic pictorial view of a collection device constructedin accordance with a fifth embodiment of the present invention;

FIG. 11 is a schematic pictorial view of a collection device constructedin accordance with a sixth embodiment of the present invention;

FIG. 12 is a schematic sectional view of a collection device constructedin accordance with a seventh embodiment of the present invention;

FIG. 13 is a schematic sectional view of a collection device constructedin accordance with an eighth embodiment of the present invention;

FIG. 14 is a schematic sectional view of the collection device of FIG.13 shown in a collapsed position; and

FIG. 15 is a schematic pictorial view of a collection device constructedin accordance with a ninth embodiment of the present invention.

DETAILED OF THE INVENTION

A collection device 10 for the collecting a biological sampleconstructed in accordance with the present invention is illustrated inFIGS. 1-5. The collection device 10 may used to collect tissue, cells,protein, RNA and/or DNA from a body lumen, such as an esophagus of apatient. The tissue, cells, protein, RNA and/or DNA collected from theesophagus may be used in any one of the methods disclosed in U.S. patentapplication Ser. Nos. 14/109,041, 13/670,155, 13/263,020, U.S. Pat. Nos.8,642,271, 8,481,707, 8,415,100, 8,221,977, 7,964,353, and 7,485,420,which are incorporated herein by reference in their entirety.

The collection device 10 includes a generally hollow longitudinallyextending collection portion 12. The collection portion 12 has a firstor proximal axial end portion 14 and a second or distal axial endportion 16. The proximal axial end portion 14 and the distal axial endportion 16 may be made of a flexible polymer, such as silicone orpolyurethane. The distal axial end portion 16 has a lower durometer thanthe proximal axial end portion 14. The distal axial end portion 16 mayexpand and contract. The first or proximal axial end portion 14 isrelatively rigid. Therefore, the proximal end portion 14 has a fixedradial extent. The first axial end portion 14 and the second axial endportion 16 may be integrally formed as one-piece or may be formed asseparate pieces that are connected together in any desire manner.Although the proximal end portion 14 is illustrated as having acylindrical shape, the proximal end portion may have any desired shape.

The proximal axial end portion 14 is connected to a support member 20,such as a catheter. The support member 20 may be a tubular member influid communication with the interior of the collection portion 12. Theproximal axial end portion 14 conducts fluid, such as air, from thesupport member 20 to the distal axial end portion 16. A proximal end ofthe support 20 may be connected to a stopcock and syringe to control theinjection of fluid to move the distal end portion 16 between thecollapsed and expanded positions. The support 20 resists collapsing whena vacuum is applied to the support member and resists stretching duringwithdrawal of the collection device 10 from the collection site.

The second or distal end portion 16 of the collection portion 12 has anexpanded or inflated position (FIG. 1) and a collapsed or deflatedposition (FIGS. 2-3). The expanded position shown in FIG. 1 may be oneof many expanded positions for the distal end portion 16. It iscontemplated that the distal end portion 16 may expand more than shownin FIG. 1 so that the distal end portion obtains a more spherical shapeand looks similar to a hot air balloon, see FIG. 15 for example. Thedistal end portion 16 has a convex shape, shown in FIG. 1, when in theexpanded or inflated position. The distal end portion 16 may extendradially outward a greater distance than the proximal end portion 14when in the expanded position.

The distal end portion 16 extends into the first or proximal axial endportion 14 and has a concave shape, shown in FIGS. 2 and 3, when in thecollapsed or deflated position. The distal end portion 16 may beinverted when in the collapsed position. The distal end portion 16extends axially into the interior of the proximal end portion 14 when inthe collapsed or deflated position. Therefore, the distal end portion 16moves axially or longitudinally relative to the proximal end portion 14when moving between the deflated and inflated positions. The distal endportion 16 may be biased into the collapsed or deflated position in anydesired manner.

The proximal end portion 14 has a relatively high durometer so that theproximal end portion does not collapse when a vacuum is applied to theproximal end portion through the support 20. The shape of the proximalend portion 14 does not change when the distal end portion 16 movesbetween the deflated and inflated positions. The proximal end portion 14does not move radially when the distal end portion 16 moves between thedeflated and inflated positions.

The distal end portion 16 of the collection portion 12 may be connectedto the proximal end portion 14 by a circumferentially extending hinge30. The hinge 30 may be a fold. The hinge 30 may extendcircumferentially around the collection portion 12. The hinge 30 definesa distal axial end surface of the collection portion 12 when the distalend portion 16 is in the deflated or collapsed position. The distal endportion 16 defines an axial end surface of the collection portion 12when the distal end portion is in the inflated or expanded position.

The distal end portion 16 has an outer surface 32 for collecting tissuewhen the distal portion is in the expanded position. The outer surface32 faces radially outwardly when the distal end portion 16 is in theexpanded position and may face radially inwardly when the distal endportion is in the collapsed or inverted position. It is contemplatedthat the outer surface 32 of the distal end portion 16 may have anydesired construction for collecting tissue. The outer surface 32 of thedistal end portion 16 may have a plurality of projections or bristles 40for collecting tissue. The distal end portion 16 may have any desirednumber of projections or bristles 40.

The projections or bristles 40 may have a V-shape (FIG. 4). Eachprojection 40 has a first side 42 and a second side 44 extending from anintersection 48. The first and second sides 42, 44 extend in a generallyproximal direction from the intersection 48 when the distal end portion16 is in the expanded position (FIG. 1). The first and second sides 42,44 extend in a generally distal direction when the distal end portion 16is in the collapsed or inverted position (FIGS. 2 and 3). The first andsecond sides 42, 44 define a cup 50 for receiving collected biologicalsamples. The cup 50 faces in a proximal direction when the distalportion 16 is in the expanded position and faces in a distal directionwhen the distal portion is in the collapsed position.

The first and second sides 42, 44 may extend at an angle ofapproximately 90° relative to each other. It is contemplated that thefirst and second sides 42 and 44 may extend at any desired anglerelative to each other. The desired angle may be determined based on thetype of biological sample to be collected. Alternatively, theprojections 40 may be cup shaped or have a semi-circular shape.

Each of the projections or bristles 40 has side walls 54 and 56 (FIG. 5)that extend radially outward from the outer surface 32 when the distalportion 16 is in the expanded position. The side walls 54 and 56 extendfrom the outer surface 32 to a radially outer surface 58 of theprojection 40. The side walls 54 and 56 taper toward each other as theside walls extend from the outer surface 32 toward the radially outersurface 58 of the projection 40. It is contemplated that the side walls54 and 56 may not taper toward each other.

The distal end portion 16 may include a plurality of projections orbristles 60 (FIG. 1) extending from a distal portion of the distal endportion 16. The projections 60 have the same general V-shape as theprojections 40 and are smaller than the projections 40. The projections60 have first and second sides 62 and 64 that have a length smaller thanthe first and second sides 42, 44 of the projections 40.

The projections or bristles 40, 60 are arranged in circumferentiallyextending rows (FIG. 1). It is contemplated that each row has sixprojections 40 or 60. It is contemplated that each of the rows may haveany desired number of projections 40 or 60. Each of the projections 40,60 is circumferentially offset from the projections on an adjacent row.Ribs 66 extend circumferentially between adjacent projections 40, 60 ineach row. The ribs 66 extend between ends of the sides walls 54, 56opposite the intersections 48.

The collection portion 12 is moved to a collection site within a bodylumen, such as an esophagus, with the distal end portion 16 in thecollapsed or deflated position. The collection portion 12 may beswallowed by a patient. It is also contemplated that the patient may beintubated with the collection portion 12 attached to a catheter. Thedistal end portion 16 may be held in the collapsed or deflated positionby the hinge 30 and/or by applying a vacuum to the collection portion 12through the support 20. The distal end portion 16 may also be held inthe collapsed position by a cap or cover that falls off, pops off and/ordissolves when the collection portion 12 reaches the body lumen. Thesupport member 20 or catheter may have depth markings to determine thecollection site within the patient's anatomy. The distal end portion 16is moved from the collapsed position to the expanded position when thecollection portion 12 is at the collection site. A pressurized fluid,such as air, may be applied to the distal end portion 16 to cause thedistal end portion to move axially from the collapsed position to theexpanded position.

The collection portion 12 is moved in the body lumen to collect abiological sample, such as, tissue, cells, protein, RNA and/or DNA fromthe collection site when the distal portion is in the expanded position.It is contemplated that the collection portion 12 is only moved in aproximal direction so that the expanded distal end portion 16 engagesthe collection site to collect biological samples. The depth markings onthe support member 20 or catheter may be used as a guide. After thebiological sample is collected, the distal end portion 16 is moved fromthe expanded position to the collapsed or inverted position. The distalend portion 16 may be moved from the expanded position to the collapsedposition by applying a vacuum to the collection portion 12. As thecollection portion 12 moves out of the body lumen, the distal endportion 16 does not engage the body lumen and prevents the collectedbiological samples from being contaminated by tissue from areas alongthe body lumen different from the collection site. Once the collectiondevice 10 is removed from the patient, the biological samples arecollected via a wash and/or the collection portion 12 or the distal endportion 16 may be cut from the support member 20 and deposited in abiological sample vial.

A second exemplary embodiment of a collection device constructed inaccordance with the present invention is illustrated in FIG. 6. Thecollection device of FIG. 6 is generally similar to the collectiondevice of FIGS. 1-5. Accordingly, similar numerals will be used todescribe similar components.

A collection device 110 (FIG. 6) includes a generally hollowlongitudinally extending collection portion 112. The collection portion112 has a first or proximal axial end portion 114 and a second or distalaxial end portion 116. The distal axial end portion 116 may expand andcontract. The proximal end portion 114 is relatively rigid. Therefore,the proximal end portion 114 has a fixed radial extent. The first axialend portion 114 and the second axial end portion 116 may be integrallyformed as one-piece or may be formed as separate pieces that areconnected together in any desired manner.

The proximal axial end portion 114 is connected to a support member 120,such as a catheter. The support member 120 may be a tubular member influid communication with the interior of the collection portion 112. Theproximal end portion 114 conducts fluid, such as air, from the supportmember 120 to the distal axial end portion 116.

The second or distal end portion 116 of the collection portion 112 hasan expanded or inflated position (FIG. 6) and a collapsed or deflatedposition similar to the position shown in FIGS. 2 and 3. The distal endportion 116 has a convex shape, shown in FIG. 6, when in the expanded orinflated position. The expanded position shown in FIG. 6 may be one ofmany expanded positions for the distal end portion 116. It iscontemplated that the distal end portion 116 may expand more than shownin FIG. 6 so that the distal end portion obtains a more spherical shapeand looks similar to a hot air balloon, see FIG. 15 for example.

The distal end portion 116 extends into the first or proximal endportion 114 and has a concave shape when in the collapsed or deflatedposition. The distal end portion 116 may be biased into the collapsed ordeflated position in any desired manner. Therefore, the distal endportion 116 moves axially relative to the proximal end portion 114 whenmoving between the deflated and inflated positions. The shape of theproximal end portion 114 does not change when the distal end portion 116moves between the deflated and inflated positions. The proximal endportion 114 does not move radially when the distal end portion 116 movesbetween the deflated and inflated positions.

The distal end portion 116 of the collection portion 112 may beconnected to the proximal end portion 114 by a circumferentiallyextending hinge 130. The hinge 130 may be a fold. The hinge 130 mayextend circumferentially around the collection portion 112. The hinge130 defines a distal axial end surface of the collection portion 112when the distal end portion 116 is in the deflated or collapsedposition. The distal end portion 116 defines an axial end surface of thecollection portion 112 when the distal end portion is in the inflated orexpanded position.

The distal end portion 116 has an outer surface 132 for collectingbiological samples. The outer surface 132 of the distal end portion 116may have a plurality of projections or ribs 140 for collectingbiological samples. The ribs 140 extend circumferentially around thedistal end portion 116 and may extend generally parallel to each other.Although the outer surface 132 is shown as having seven projections orribs 140, it is contemplated that the outer surface may have any desirednumber of ribs. The ribs 140 may extend radially from the outer surface132 any distance. It is also contemplated that the ribs 140 may extenddifferent distances from the outer surface 132.

A third exemplary embodiment of a collection device constructed inaccordance with the present invention is illustrated in FIG. 7. Thecollection device of FIG. 7 is generally similar to the collectiondevices of FIGS. 1-6. Accordingly, similar numerals will be used todescribe similar components.

A collection device 210 (FIG. 7) includes a generally hollowlongitudinally extending collection portion 212. The collection portion212 has a first or proximal axial end portion 214 and a second or distalaxial end portion 216. The distal axial end portion 216 may expand andcontract. The proximal end portion 214 is relatively rigid. Therefore,the proximal end portion 214 has a fixed radial extent. The first axialend portion 214 and the second axial end portion 216 may be integrallyformed as one-piece or may be formed as separate pieces that areconnected together in any desired manner.

The proximal end portion 214 has a fixed radial extent. The proximalaxial end portion 214 is connected to a support member 220, such as acatheter. The support member 220 may be a tubular member in fluidcommunication with the interior of the collection portion 212. Theproximal axial end portion 214 conducts fluid, such as air, from thesupport member 20 to the distal axial end portion 216.

The distal end portion 216 of the collection portion 212 has an expandedor inflated position (FIG. 7) and a collapsed or deflated positionsimilar to the position shown in FIGS. 2 and 3. The expanded positionshown in FIG. 7 may be one of many expanded positions for the distal endportion 216. It is contemplated that the distal end portion 216 mayexpand more than shown in FIG. 7 so that the distal end portion obtainsa more spherical shape and looks similar to a hot air balloon, see FIG.15 for example. The distal end portion 216 has a convex shape, shown inFIG. 7, when in the expanded or inflated position.

The distal end portion 216 extends into the proximal end portion 214 andhas a concave shape when in the collapsed or deflated position.Therefore, the distal end portion 216 moves axially relative to theproximal end portion 214 when moving between the deflated and inflatedpositions. The distal end portion 216 may be biased into the collapsedor deflated position in any desired manner. The shape of the proximalend portion 214 does not change when the distal end portion 216 movesbetween the deflated and inflated positions. The proximal end portion214 does not move radially when the distal end portion 216 moves betweenthe deflated and inflated positions.

The distal end portion 216 of the collection portion 212 may beconnected to the proximal end portion 214 by a circumferentiallyextending hinge 230. The hinge 230 may be a fold. The hinge 230 mayextend circumferentially around the collection portion 212. The hinge230 defines a distal axial end surface of the collection portion 212when the distal end portion 216 is in the deflated or collapsedposition. The distal end portion 216 defines an axial end surface of thecollection portion 212 when the distal end portion is in the inflated orexpanded position.

The distal end portion 216 has an outer surface 232 for collectingbiological samples. The outer surface 232 of the distal end portion 216may have a plurality of projections or bristles 240 for collectingbiological samples. The projections 240 have a generally cylindricalshape. The outer surface 232 may have any desired number of projections240. The projections 240 may extend radially from the outer surface 232any distance. It is also contemplated that the projections 240 mayextend different distances from the outer surface 232. The projections240 may have any desired diameters and may have different diameters.

A fourth exemplary embodiment of a collection device constructed inaccordance with the present invention is illustrated in FIGS. 8 and 9.The collection device of FIGS. 8 and 9 is generally similar to thecollection devices of FIGS. 1-7. Accordingly, similar numerals will beused to describe similar components.

A collection device 310 (FIGS. 8-9) includes a generally hollowlongitudinally extending tissue collection portion 312. The collectionportion 312 has a first or proximal axial end portion 314 and a secondor distal axial end portion 316. The distal axial end portion 316 mayexpand and contract. The proximal end portion 314 is relatively rigid.Therefore, the proximal end portion 314 has a fixed radial extent. Thefirst axial end portion 314 and the second axial end portion 316 may beintegrally formed as one-piece or may be formed as separate pieces thatare connected together in any desired manner.

The proximal end portion 314 has a fixed radial extent. The proximalaxial end portion 314 is connected to a support member 320, such as acatheter. The support member 320 may be a tubular member in fluidcommunication with the interior of the collection portion 312. Theproximal axial end portion 314 conducts fluid from the support member320 to the distal axial end portion 316.

The distal end portion 316 of the collection portion 312 has an expandedor inflated position (FIG. 8) and a collapsed or deflated positionsimilar to the position shown in FIGS. 2 and 3. The expanded positionshown in FIG. 8 may be one of many expanded positions for the distal endportion 316. It is contemplated that the distal end portion 316 mayexpand more than shown in FIG. 8 so that the distal end portion obtainsa more spherical shape and looks similar to a hot air balloon, see FIG.15 for example. The distal end portion 316 has a convex shape, shown inFIG. 8, when in the expanded or inflated position.

The distal end portion 316 extends into the proximal end portion 314 andhas a concave shape when in the collapsed or deflated position.Therefore, the distal end portion 316 moves axially relative to theproximal end portion 314 when moving between the deflated and inflatedpositions. The distal end portion 316 may be biased into the collapsedor deflated position in any desired manner. The shape of the proximalend portion 314 does not change when the distal end portion 316 movesbetween the deflated and inflated positions. The proximal end portion314 does not move radially when the distal end portion 316 moves betweenthe deflated and inflated positions.

The distal end portion 316 of the collection portion 312 may beconnected to the proximal end portion 314 by a circumferentiallyextending hinge 330. The hinge 330 may be a fold. The hinge 330 mayextend circumferentially around the collection portion 312. The hinge330 defines a distal axial end surface of the collection portion 312when the distal end portion 316 is in the deflated or collapsedposition. The distal end portion 316 defines an axial end surface of thecollection portion 312 when the distal end portion is in the inflated orexpanded position.

The distal end portion 316 has an outer surface 332 for collectingbiological samples. The outer surface 332 is generally cylindrical. Theouter surface 332 has an axially extending surface 334 and an axial endsurface 336. The axially extending surface 334 of the outer surface 332may have a plurality of projections or bristles 340 for collectingtissue. It is contemplated that the axial end surface 336 may alsoinclude projections 340.

Each of the projections 340 has a support portion 342 (FIG. 9). Thesupport portion 342 may have a bi-directional curve shape or S-shapeextending radially outward from the outer surface 332. A bi-directionalcurve shaped or S-shaped portion 344 having a cross-section larger thanthe support portion 342 extends from the support portion, as shown inFIG. 9. The outer surface 332 may have any desired number of projections340. The projections 340 may extend radially from the outer surface 332any distance. It is also contemplated that the projections 340 mayextend different distances from the outer surface 332.

A fifth exemplary embodiment of a collection device constructed inaccordance with the present invention is illustrated in FIG. 10. Thecollection device of FIG. 10 is generally similar to the collectiondevices of FIGS. 1-9. Accordingly, similar numerals will be used todescribe similar components.

A collection device 410 (FIG. 10) includes a generally hollowlongitudinally extending collection portion 412. The collection portion412 has a first or proximal axial end portion 414 and a second or distalaxial end portion 416. The distal axial end portion 416 may expand andcontract. The proximal end portion 414 is relatively rigid. Therefore,the proximal end portion 414 has a fixed radial extent. The first axialend portion 414 and the second axial end portion 416 may be integrallyformed as one-piece or may be formed as separate pieces that areconnected together in any desired manner.

The proximal end portion 414 has a fixed radial extent. The proximalaxial end portion 414 is connected to a support member 420, such as acatheter. The support member 420 may be a tubular member in fluidcommunication with the interior of the collection portion 412. Theproximal end portion 414 conducts fluid, such as air, from the supportmember 420 to the distal axial end portion 416.

The distal end portion 416 of the collection portion 412 has an expandedor inflated position (FIG. 10) and a collapsed or deflated positionsimilar to the position shown in FIGS. 2 and 3. The expanded positionshown in FIG. 10 may be one of many expanded positions for the distalend portion 416. It is contemplated that the distal end portion 416 mayexpand more than shown in FIG. 10 so that the distal end portion obtainsa more spherical shape and looks similar to a hot air balloon, see FIG.15 for example. The distal end portion 16 has a convex shape, shown inFIG. 10, when in the expanded or inflated position.

The distal end portion 416 extends into the proximal end portion and hasa concave shape when in the collapsed or deflated position. Therefore,the distal end portion 416 moves axially relative to the proximal endportion 414 when moving between the deflated and inflated positions. Thedistal end portion 416 may be biased into the collapsed or deflatedposition in any desired manner. The shape of the proximal end portion414 does not change when the distal end portion 416 moves between thedeflated and inflated positions. The proximal end portion 414 does notmove radially when the distal end portion 416 moves between the deflatedand inflated positions.

The distal end portion 416 of the collection portion 412 may beconnected to the proximal end portion 414 by a circumferentiallyextending hinge 430. The hinge 430 may be a fold. The hinge 430 mayextend circumferentially around the collection portion 412. The hinge430 defines a distal axial end surface of the collection portion 412when the distal end portion 416 is in the deflated or collapsedposition. The distal end portion 416 defines an axial end surface of thecollection portion 412 when the distal end portion is in the inflated orexpanded position.

The distal end portion 416 has an outer surface 432 for collectingbiological samples. The outer surface 432 of the distal end portion 416may have a plurality of projections or bristles 440 for collectingbiological samples. The projections or bristles 440 may have a V-shapeand be generally similar to the V-shaped projections 40 described inconnection with the embodiment illustrated in FIGS. 1-5. Each projection440 has a side 442 and a second side 444 extending in a generallyproximal direction from an intersection 448 when the distal end portion416 is in the expanded position. Therefore, the first and second sides442, 444 define a proximally facing cup 450 for receiving collectedtissue. The first and second sides 442, 444 extend at an angle to eachother. The first and second sides 442, 444 may extend at an angle ofapproximately 90° relative to each other. It is contemplated that thefirst and second sides 442 and 444 may extend at any desired anglerelative to each other. The desired angle may be determined based on thetype of biological sample to be collected.

The distal end portion 416 may include a plurality of projections orbristles 460 extending from a distal portion of the distal end portion416. The projections 460 have the same general V-shape as theprojections 440. The projections 460 are smaller than the projections440 and are located distally to the projections 440 when the distal endportion 416 is in the expanded position.

A sixth exemplary embodiment of a collection device constructed inaccordance with the present invention is illustrated in FIG. 11. Thecollection device of FIG. 10 is generally similar to the collectiondevices of FIGS. 1-10. Accordingly, similar numerals will be used todescribe similar components.

A collection device 510 (FIG. 11) includes a generally hollowlongitudinally extending collection portion 512. The collection portion512 has a first or proximal axial end portion 514 and a second or distalaxial end portion 516. The distal axial end portion 516 may expand andcontract. The proximal end portion 514 is relatively rigid. Therefore,the proximal end portion 514 has a fixed radial extent. The first axialend portion 514 and the second axial end portion 516 may be integrallyformed as one-piece or may be formed as separate pieces that areconnected together in any desired manner.

The proximal end portion 514 has a fixed radial extent. The proximalaxial end portion 514 is connected to a support member 520, such as acatheter. The support member 520 may be a tubular member in fluidcommunication with the interior of the collection portion 512. Theproximal end portion 514 conducts fluid from the support member 520 tothe distal axial end portion 516.

The distal end portion 516 of the collection portion 512 has an expandedor inflated position (FIG. 11) and a collapsed or deflated positionsimilar to the position shown in FIGS. 2 and 3. The expanded positionshown in FIG. 11 may be one of many expanded positions for the distalend portion 516. It is contemplated that the distal end portion 516 mayexpand more than shown in FIG. 11 so that the distal end portion obtainsa more spherical shape and looks similar to a hot air balloon, see FIG.15 for example. The distal end portion 16 has a convex shape, shown inFIG. 11, when in the expanded or inflated position.

The distal end portion 516 extends into the proximal end portion 514 andhas a concave shape when in the collapsed or deflated position.Therefore, the distal end portion 516 moves axially relative to theproximal end portion 514 when moving between the deflated and inflatedpositions. The distal end portion 516 may be biased into the collapsedor deflated position in any desired manner. The shape of the proximalend portion 514 does not change when the distal end portion 516 movesbetween the deflated and inflated positions. The proximal end portion514 does not move radially when the distal end portion 516 moves betweenthe deflated and inflated positions.

The distal end portion 516 of the collection portion 512 may beconnected to the proximal end portion 514 by a circumferentiallyextending hinge 530. The hinge 530 may be a fold. The hinge 530 mayextend circumferentially around the collection portion 512. The hinge530 defines a distal axial end surface of the collection portion 512when the distal end portion 516 is in the deflated or collapsedposition. The distal end portion 516 defines an axial end surface of thecollection portion 512 when the distal end portion is in the inflated orexpanded position.

The distal end portion 516 has an outer surface 532 for collectingbiological samples. The outer surface 532 of the distal end portion 516may have a plurality of projections or bristles 540 for collectingbiological samples. The projections or bristles 540 may have an X-shape.The distal end portion 516 may include a plurality of projections orbristles 560 extending from a distal portion of the distal end portion516. The projections 560 have the same general X-shape as theprojections 540. However, the projections 560 are smaller than theprojections 540.

A seventh exemplary embodiment of a collection device constructed inaccordance with the present invention is illustrated in FIG. 12. Thecollection device of FIG. 12 is generally similar to the collectiondevices of FIGS. 1-11. Accordingly, similar numerals will be used todescribe similar components.

A collection device 610 (FIG. 12) includes a generally hollowlongitudinally extending collection portion 612. The collection portion612 has a first or proximal axial end portion 614 and a second or distalaxial end portion 616. The distal axial end portion 616 may expand andcontract. The proximal end portion 614 is relatively rigid. Therefore,the proximal end portion 614 has a fixed radial extent.

The proximal axial end portion 614 is connected to a support member,such as a catheter. The support member may be a tubular member in fluidcommunication with the interior of the collection portion 612. Theproximal end portion 614 conducts fluid from the support member to thedistal end portion 616.

The distal end portion 616 has a first axial end portion 622 connectedto the proximal axial end portion 614. The first end portion 622 may beconnected to the proximal end portion 614 in any desired manner, such asby using an adhesive. The first axial end portion 622 engages a shoulder624 on the proximal axial end portion 614. Therefore, the collectionportion 612 has a smooth outer surface.

The distal end portion 616 of the collection portion 612 has an expandedor inflated position (FIG. 12) and a collapsed or deflated positionsimilar to the position shown in FIGS. 2 and 3. The expanded positionshown in FIG. 12 may be one of many expanded positions for the distalend portion 616. It is contemplated that the distal end portion 616 mayexpand more than shown in FIG. 12 so that the distal end portion obtainsa more spherical shape and looks similar to a hot air balloon, see FIG.15 for example. The distal end portion 16 has a convex shape, shown inFIG. 12, when in the expanded or inflated position.

The distal end portion 616 extends into the proximal end portion 614 andhas a concave shape when in the collapsed or deflated position.Therefore, the distal end portion 616 moves axially relative to theproximal end portion 614 when moving between the deflated and inflatedpositions. The distal end portion 616 may be biased into the collapsedor deflated position in any desired manner. The shape of the proximalend portion 614 does not change when the distal end portion 616 movesbetween the deflated and inflated positions. The proximal end portion614 does not move radially when the distal end portion 616 moves betweenthe deflated and inflated positions.

The distal end portion 616 of the collection portion 612 may beconnected to the proximal end portion 614 at a circumferentiallyextending hinge 630. The hinge 630 may extend circumferentially aroundthe collection portion 612. The hinge 630 defines a distal axial endsurface of the collection portion 612 when the distal end portion 616 isin the deflated or collapsed position. The distal end portion 616defines an axial end surface of the collection portion 612 when thedistal end portion is in the inflated or expanded position.

The distal end portion 616 has an outer surface 632 for collectingbiological samples. It is contemplated that the outer surface 632 of thedistal end portion 616 may have any desired construction for collectingbiological samples. The outer surface 632 of the distal end portion 616may have a plurality of projections or bristles for collectingbiological samples. The projections or bristles may have any desiredshape, such as the shapes shown in FIGS. 1-11.

An eighth exemplary embodiment of a collection device constructed inaccordance with the present invention is illustrated in FIGS. 13-14. Thecollection device of FIGS. 13-14 is generally similar to the collectiondevices of FIGS. 1-12. Accordingly, similar numerals will be used todescribe similar components.

A collection device 710 (FIG. 11) includes a generally hollowlongitudinally extending collection portion 712. The collection portion712 has a first or proximal axial end portion 714 and a second or distalaxial end portion 716. The distal axial end portion 716 may expand andcontract. The proximal end portion 714 is relatively rigid. Therefore,the proximal end portion 714 has a fixed radial extent. The first axialend portion 714 and the second axial end portion 716 may be integrallyformed as one-piece or may be formed as separate pieces that areconnected together in any desired manner.

The proximal end portion 714 has a fixed radial extent. The proximalaxial end portion 714 is connected to a support member 720. The supportmember 720 may be a tubular member in fluid communication with theinterior of the collection portion 712. The proximal end portion 714conducts fluid from the support member 720 to the distal end portion716.

The distal end portion 716 of the collection portion 712 has an expandedor inflated position (FIG. 13) and a collapsed or deflated position(FIG. 14). The expanded position shown in FIG. 13 may be one of manyexpanded positions for the distal end portion 716. It is contemplatedthat the distal end portion 716 may expand more than shown in FIG. 13 sothat the distal end portion obtains a more spherical shape and lookssimilar to a hot air balloon, see FIG. 15 for example. The distal endportion 716 has a convex shape, shown in FIG. 13, when in the expandedor inflated position.

The distal end portion 716 extends into the proximal end portion 714 andhas a concave shape when in the collapsed or deflated position, as shownin FIG. 14. The distal end portion 716 only moves axially relative tothe proximal end portion 714 when moving between the deflated andinflated positions. The distal end portion 716 may be biased into thecollapsed or deflated position in any desired manner. The shape of theproximal end portion 714 does not change when the distal end portion 716moves between the deflated and inflated positions. The proximal endportion 714 does not move radially when the distal end portion 716 movesbetween the deflated and inflated positions.

The distal end portion 716 of the collection portion 712 may beconnected to the proximal end portion 714 by a circumferentiallyextending hinge 730. The hinge 730 may be a fold. The hinge 730 mayextend circumferentially around the collection portion 712. The hinge730 defines a distal axial end surface of the collection portion 712when the distal end portion 716 is in the deflated or collapsedposition. The distal end portion 716 defines an axial end surface of thecollection portion 712 when the distal end portion is in the inflated orexpanded position.

The distal end portion 716 has an outer surface 732 for collectingbiological samples. It is contemplated that the outer surface 732 of thedistal end portion 716 may have any desired construction for collectingbiological samples. The outer surface 732 of the distal end portion 716may have a plurality of projections or bristles 740 for collectingbiological samples. The outer surface 732 may have any desired number ofprojections 740.

A ninth exemplary embodiment of a collection device constructed inaccordance with the present invention is illustrated in FIG. 15. Thecollection device of FIG. 15 is generally similar to the collectiondevice of FIGS. 1-14. Accordingly, similar numerals will be used todescribe similar components.

A collection device 810 (FIG. 15) includes a generally hollowlongitudinally extending collection portion 812. The collection portion812 has a first or proximal axial end portion 814 and a second or distalaxial end portion 816. The distal axial end portion 816 may expand andcontract. The proximal end portion 814 is relatively rigid. Therefore,the proximal end portion 814 has a fixed radial extent. The first axialend portion 814 and the second axial end portion 816 may be integrallyformed as one-piece or may be formed as separate pieces that areconnected together in any desired manner.

The proximal axial end portion 814 is connected to a support member 820,such as a catheter. The support member 820 may be a tubular member influid communication with the interior of the collection portion 812. Theproximal end portion 814 conducts fluid, such as air, from the supportmember 820 to the distal axial end portion 816.

The second or distal end portion 816 of the collection portion 812 hasan expanded or inflated position (FIG. 15) and a collapsed or deflatedposition similar to the position shown in FIGS. 2 and 3. The distal endportion 816 has a convex shape, shown in FIG. 15, when in the expandedor inflated position. The expanded position shown in FIG. 15 may be oneof many expanded positions for the distal end portion 816. It iscontemplated that the distal end portion 816 may expand less than shownin FIG. 15 so that the distal end portion obtains a more oblong shapeand looks similar to the distal end portion 16 shown in FIG. 1.

The distal end portion 816 extends into the first or proximal endportion 814 and has a concave shape when in the collapsed or deflatedposition. The distal end portion 816 may be biased into the collapsed ordeflated position in any desired manner. Therefore, the distal endportion 816 moves axially relative to the proximal end portion 814 whenmoving between the deflated and inflated positions. The shape of theproximal end portion 814 does not change when the distal end portion 816moves between the deflated and inflated positions. The proximal endportion 814 does not move radially when the distal end portion 816 movesbetween the deflated and inflated positions.

The distal end portion 816 of the collection portion 812 may beconnected to the proximal end portion 814 by a circumferentiallyextending hinge 830. The hinge 830 may be a fold. The hinge 830 mayextend circumferentially around the collection portion 812. The hinge830 defines a distal axial end surface of the collection portion 812when the distal end portion 816 is in the deflated or collapsedposition. The distal end portion 816 defines an axial end surface of thecollection portion 812 when the distal end portion is in the inflated orexpanded position. The distal end portion 816 has an outer surface 832for collecting biological samples. The outer surface 832 of the distalend portion 816 may have a textured surface or include a plurality ofprojections or ribs for collecting biological samples.

Each of the collection portions of the described collection devices ismoved to a collection site within a body lumen, such as an esophagus,with the distal end portion in the collapsed or deflated position. Thecollection portion may be swallowed by a patient. The distal end portionmay be held in the collapsed or deflated position by the hinge and/or byapplying a vacuum to the collection portion through the support. Thedistal end portion may also be held in the collapsed position by a capor cover that falls off, pops off and/or dissolves when the collectionportion reaches the collection site. The distal end portion is movedfrom the collapsed position to the expanded position when the collectionportion is at the collection site. The collection portion is moved inthe body lumen to collect biological samples, such as, tissue, cells,protein, RNA and/or DNA from the collection site when the distal portionis in the expanded position. After the biological sample is collected,the distal end portion is moved from the expanded position to thecollapsed position. As the collection portion moves out of the bodylumen, the distal end portion does not engage the body lumen andprevents the collected biological samples from being contaminated bytissue from areas along the body lumen different from the collectionsite.

The collection devices described above may be formed as one-piece orformed as separate pieces that are connected together. Also, it iscontemplated that the projections or bristles may have any desiredshape. Accordingly, the tissue collection devices may have at least oneV-shaped projection and/or at least one circumferentially extending riband/or at least one cylindrical projection and/or at least onebi-directional curved shaped projection and/or at least one X-shapedprojection. It is also contemplated that each of the collection devicesmay have circumferentially extending ribs extending between adjacentprojections.

From the above description of the invention, those skilled in the artwill perceive improvements, changes and modifications. Suchimprovements, changes and modifications are intended to be covered bythe appended claims.

What is claimed is:
 1. A device for collecting a biological sample in apatient, the device comprising a collection portion sized to beswallowed by the patient, the collection portion having a first axialend portion and a second axial end portion, the second axial end portionincludes a first set of projections, and the first set of projectionsbeing arranged in rows of projections, each of the rows of projectionshaving projections that are spaced from one another.
 2. A device forcollecting a biological sample as set forth in claim 1, wherein thesecond axial end portion includes a collapsed position and an expandedposition, the second axial end portion being capable of moving in anaxial direction relative to the first axial end portion when the secondaxial end portion moves between the collapsed position and the expandedposition.
 3. A device for collecting a biological sample as set forth inclaim 1 wherein projections of the first set of projections have aV-shape.
 4. A device for collecting a biological sample as set forth inclaim 3 wherein the projections have first and second sides extendingfrom an intersection at an angle to each other, the first and secondsides extending toward the first axial end portion from the intersectionwhen the second axial end portion is in an expanded position.
 5. Adevice for collecting a biological sample as set forth in claim 1wherein circumferentially extending ribs extend between adjacentprojections.
 6. A device for collecting a biological sample as set forthin claim 1 wherein side walls of the projections taper toward each otheras the side walls extend radially outward from the collection portion.7. A device for collecting a biological sample as set forth in claim 1wherein the first set of projections includes at least onecircumferentially extending rib.
 8. A device for collecting a biologicalsample as set forth in claim 1 wherein the first set of projectionsincludes at least one radially extending cylindrical projection.
 9. Adevice for collecting a biological sample as set forth in claim 1wherein the first set of projections includes at least onebi-directional curved shaped projection.
 10. A device for collecting abiological sample as set forth in claim 9 wherein the at least onebi-directional curved shaped projection includes a support portionextending radially outward from the second axial end portion and abi-directional curve shaped portion having a cross-section larger thanthe support portion.
 11. A method for collecting a biological samplefrom a collection site of an lumen of a patient, the method comprising:moving a collection portion of a device having a first axial end portionand a second axial end portion to a collection site in a lumen of apatient with the second axial end portion in a collapsed positionextending axially into the first axial end portion, the second axial endportion including a first set of tissue collecting projections; axiallymoving the second axial end portion relative to the first axial endportion from the collapsed position into an expanded position to exposethe first set of tissue collecting projections; collecting a biologicalsample with the first set of tissue collecting projections of the secondaxial end portion, when the second axial end portion is in the expandedposition; collapsing the second axial end portion into the first axialend portion; and withdrawing the device from the lumen of the patient.12. A method for collecting a biological sample from a lumen as setforth in claim 11 wherein the first set of tissue collecting projectionsengage a surface of the collection site of the lumen of the patient tocollect the biological sample.
 13. A method for collecting a biologicalsample from a lumen as set forth in claim 12 wherein the step ofcollapsing the second axial end portion into the first axial end portionincludes cupping the collected biological sample with the first set oftissue collecting projections.
 14. A method for collecting a biologicalsample from a lumen as set forth in claim 11 wherein the step ofcollecting a biological sample includes collecting cells.
 15. A methodfor collecting a biological sample from a lumen as set forth in claim 11wherein the step of collecting a biological sample includes collectingDNA and/or RNA.
 16. A method for collecting a biological sample from alumen as set forth in claim 11 wherein the step of axially moving thesecond axial end portion from the collapsed position into the expandedposition includes moving the second axial end portion from a concaveshape to a convex shape.
 17. A method for collecting a biological samplefrom a lumen as set forth in claim 11 wherein the step of collapsing thesecond axial end portion from the expanded position into the collapsedposition includes moving the second axial end portion from a convexshape to a concave shape.
 18. A method for collecting a biologicalsample from a lumen as set forth in claim 11 wherein the step ofcollapsing the second axial end portion from the expanded position intothe collapsed position includes causing the first set of tissuecollecting projections of the second axial end portion facing radiallyoutwardly when the second axial end portion is in the expanded positionto face radially inwardly when the second axial end portion is in thecollapsed position.
 19. A method for collecting a biological sample froma lumen as set forth in claim 11, wherein the lumen is an esophagus ofthe patient, and wherein the step of moving the collection portion ofthe device into the lumen includes swallowing the collection portion orintubating the patient with the collection portion.
 20. A method forcollecting a biological sample from a lumen as set forth in claim 11wherein the step of removing the device from the lumen includespreventing the second axial end portion of the collection portion fromengaging the lumen at an area different from the collection site.
 21. Amethod for collecting a biological sample from a lumen as set forth inclaim 11 wherein the step of axially moving the second axial end portionfrom the collapsed position into the expanded position includes applyingpressurized air to the second axial end portion and the step of axiallymoving the second axial end portion from the expanded position into thecollapsed position includes applying a vacuum to the collection portion.22. A sample collection device for collecting a sample in a patient, thedevice comprising a collection portion having a first axial end portionand a second axial end portion; wherein the second axial end portionincludes a first set of projections and a second set of projections, thefirst set of projections and the second set of projections havingdifferent shapes; and wherein the collection portion is configured to beswallowed by the patient.
 23. A sample collection device for collectinga sample as set forth in claim 22, wherein the second axial end portionincludes a collapsed position and an expanded position, the second axialend portion being capable of moving in an axial direction relative tothe first axial end portion when the second axial end portion movesbetween the collapsed position and the expanded position.
 24. A samplecollection device for collecting a sample as set forth in claim 22,wherein the first set of projections are axially aligned at a firstaxial location on the second axial end portion and the second set ofprojections are axially aligned at a second axial location on the secondaxial end portion.
 25. A sample collection device for collecting asample as set forth in claim 24, wherein the second set of projectionsis a plurality of sets of projections and each respective set ofprojections are axially aligned at different axial locations on thesecond axial end portion.
 26. A device for placement of a collectionportion at a collection site for collection of a biological sample in apatient, the device comprising: a collection portion having a firstaxial end portion and a second axial end portion, the second axial endportion includes a first set of projections, each of the first set ofprojections having a cylindrical shape; wherein the collection portionis sized and dimensioned to be swallowed by the patient.
 27. A devicefor placement of a collection portion at a collection site as set forthin claim 26, wherein the first set of projections include bristles. 28.A device for placement of a collection portion at a collection site asset forth in claim 26, wherein the first set of projections include aplurality of projections which extend a plurality of distances away fromthe second axial end portion.
 29. A device for placement of a collectionportion at a collection site as set forth in claim 26, wherein the firstset of projections include a plurality of projections which havedifferent diameters.
 30. A device for placement of a collection portionat a collection site as set forth in claim 26, wherein the second axialend portion includes a collapsed position and an expanded position, thesecond axial end portion moving in an axial direction relative to thefirst axial end portion when the second axial end portion moves betweenthe collapsed position and the expanded position.